title: Fractional flow reserve versus angiography in guiding management to optimize outcomes in non-ST-elevation myocardial infarction (FAMOUS-NSTEMI): rationale and design of a randomized controlled clinical trial.
abstract: BACKGROUND
  In patients with acute non-ST-elevation myocardial infarction (NSTEMI), coronary arteriography is usually recommended; but visual interpretation of the angiogram is subjective. We hypothesized that functional assessment of coronary stenosis severity with a pressure-sensitive guide wire (fractional flow reserve [FFR]) would have additive diagnostic, clinical, and health economic utility as compared with angiography-guided standard care.
  
  
  METHODS
  A prospective multicenter parallel-group 1:1 randomized controlled superiority trial in 350 NSTEMI patients with ≥1 coronary stenosis ≥30% severity (threshold for FFR measurement) will be conducted. Patients will be randomized immediately after coronary angiography to the FFR-guided group or angiography-guided group. All patients will then undergo FFR measurement in all vessels with a coronary stenosis ≥30% severity including culprit and nonculprit lesions. Fractional flow reserve will be disclosed to guide treatment in the FFR-guided group but not disclosed in the "angiography-guided" group. In the FFR-guided group, an FFR ≤0.80 will be an indication for revascularization by percutaneous coronary intervention or coronary artery bypass surgery, as appropriate. The primary outcome is the between-group difference in the proportion of patients allocated to medical management only compared with revascularization. Secondary outcomes include the occurrence of cardiac death or hospitalization for myocardial infarction or heart failure, quality of life, and health care costs. The minimum and average follow-up periods for the primary analysis are 6 and 18 months, respectively.
  
  
  CONCLUSIONS
  Our developmental clinical trial will address the feasibility of FFR measurement in NSTEMI and the influence of FFR disclosure on treatment decisions and health and economic outcomes.
authors.affiliation: West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom; BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom. Electronic address: colin.berry@glasgow.ac.uk.
authors.forename: Colin
authors.initials: C
authors.lastname: Berry
authors.forename: Jamie
authors.initials: J
authors.lastname: Layland
authors.forename: Arvind
authors.initials: A
authors.lastname: Sood
authors.forename: Nick P
authors.initials: NP
authors.lastname: Curzen
authors.forename: Kanarath P
authors.initials: KP
authors.lastname: Balachandran
authors.forename: Raj
authors.initials: R
authors.lastname: Das
authors.forename: Shahid
authors.initials: S
authors.lastname: Junejo
authors.forename: Robert A
authors.initials: RA
authors.lastname: Henderson
authors.forename: Andrew H
authors.initials: AH
authors.lastname: Briggs
authors.forename: Ian
authors.initials: I
authors.lastname: Ford
authors.forename: Keith G
authors.initials: KG
authors.lastname: Oldroyd
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000191:economics / Q000379:methods*; D017023:Coronary Angiography / Q000191:economics / Q000379:methods*; D001026:Coronary Artery Bypass / Q000191:economics / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D053805:Fractional Flow Reserve, Myocardial / Q000502:physiology*; D017048:Health Care Costs; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D011446:Prospective Studies; D016896:Treatment Outcome